UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes
Acronym	Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Scientific Title	Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Scientific Title:Acronym	Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we targeted patients with type 2 diabetes by measuring CCL11 (eotaxin) and CCL22 (MDC), one of the chemokines, and IL-6 and IL-18, which are one of the cytokines. The purpose of this study is to analyze the clinical significance of the three major complications of patients with diabetic neuropathy, insulin resistance, arteriosclerosis, and other blood sampling . In addition, urinary metabolomics and urinary NGAL are measured, the relationship with diabetic neuropathy is considered, and the aim is to search for new clinical markers that are considered necessary for future treatment of diabetic neuropathy.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to analyze the clinical significance of the three major complications mainly of diabetic neuropathy, insulin resistance, arteriosclerosis, and various blood sampling items in type 2 diabetic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical significance of serum chemokine levels in patient with diabetes and diabetic neuropathy.
Key secondary outcomes	Time of measurement: early in the morning, fasting Measurement items (LSI): CCL11 (eotaxin) CCL22 (MDC) IL-6 IL-18 Urine Metabolomics U-NGAL serum: FGF21 BDNF HMW adiponectin IL-33s TNF-R1 & -R2 Relationship with diabetic complications: peripheral neuropathy: staging, nerve conduction test, CVR-R Orthostatic hypotension (Sheron test) Timed up and Go test, Monofilament Nephropathy: eGFR UAE Retinopathy: Stage Relationship with insulin resistance: BMI, InBody, DualScan Relationship with arteriosclerosis: CAVI / ABI FMD carotid IMT Routine examination at admission + IgE + TARC + Beta-hydroxyl-butyrate + M2BPG (i Mac-2 binding protein sugar chain modification isomer), Ca, P, active Vitamin D3 Heart rate variability (HRV): CVR-R, power spectrum analysis (PSA) The severity of diabetic kidney disease Coagulation fibrinolysis system: vWF, d dimer, etc. Arterial stiffness: PWV, CAVI abdominal echo

Base
Study type	Observational

Study design
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Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 6.5 and 12.0%) under medical treatment by dieting and exercise cure and/or drug treatment. 2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)Patients with no history of cardiovascular disease 5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 6)The patient who gives a written informed
Key exclusion criteria	1)Type 1 diabetes 2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)Patient with intolerance of medical reasons by doctor.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Teruo Middle name Last name Jojima
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Zip code	321-0293
Address	880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL	0828-87-2150
Email	jojima@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Teruo Middle name Last name Jojima
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Zip code	321-0293
Address	880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL	0282-87-2150
Homepage URL
Email	jojima@dokkyomed.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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Name of secondary funder(s)

IRB Contact (For public release)
Organization	Dokkyo Medical University
Address	880kita-kobayashi,Mibu,Tochigi,Japan
Tel	0282-87-2275
Email	r-kenkyu@dokkyomed.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
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IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	cross section study

Management information
Registered date	2020 Year 06 Month 02 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046344

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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